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510(k) K823622

INSULATED THERMOELASTOMER MITT by Fred Sammons, Inc. — Product Code IMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1982
Date Received
December 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Heat, Moist
Device Class
Class I
Regulation Number
890.5730
Review Panel
PM
Submission Type

Other clearances by Fred Sammons, Inc.

  • K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) (May 6, 1988)
  • K880647 — ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) (April 1, 1988)
  • K831549 — ARM SLINGS (June 30, 1983)
  • K831548 — SPLINTS (June 27, 1983)
  • K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035 (June 24, 1983)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (June 24, 1983)
  • K831550 — FINGER BONIOMETER BK7506 (June 24, 1983)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
  • K831553 — LEG DRAINAGE BAG STRAP BK6011 (June 16, 1983)
  • K831547 — RAISED TOILET SEATS & NAIL CLIPPERS (June 8, 1983)

Other clearances for product code IMA

  • K150139 — Rachel's Remedy (May 22, 2015)
  • K950701 — WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER (March 24, 1995)
  • K841698 — HEAT PACK (May 10, 1984)
  • K832803 — STEAM PAK MOIST HEAT (September 20, 1983)
  • K803177 — MOIST HEAT PACK (December 31, 1980)
  • K791653 — REUSABLE MOIST HEAT PACK (September 7, 1979)
  • K790904 — STAO-HOTPACK (May 18, 1979)